MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX20

Device Problems Incomplete Coaptation (2507); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

As reported by an edwards lifesciences affiliate in the united kingdom, regarding a 20mm sapien 3 ultra valve.During device preparation, while washing the valve for crimping it was noticed no coaptation between the leaflets.The thv tamper seal was not broken and the valve and holder were removed without touching the tissue.The valve was rejected.Another 20mm s3u was successfully used in replacement, and the patient was noted as to have a great outcome.Per additional valve inspection with irvine implant manufacturing (iim), the leaflet crease was observed at cp2.

Manufacturer Narrative

Investigation is underway.

Manufacturer Narrative

The device was returned for evaluation.The returned device was visually examined for any abnormalities and the following was observed: upon opening the jar, leaflet cp3 was in opened position.Leaflets cp1 and cp2 were in closed position.When tested with probe: flex open leaflets to closed position: leaflet cp3 flexed back to the opened position.Flex closed leaflets to open position: leaflet cp1 flexed back to the closed position.Leaflet cp2 stayed opened.The returned valve was visually observed in solution, and the reported appearance/behavior of the leaflets were observed.Leaflet cp3 opened and closed with oscillation.Leaflet cp1 and cp2 remained closed at all times with oscillation.Per manufacturing inspection, crease was observed across leaflet at cp2.The returned valve was further tested for proper coaptation under nominal simulated physiological patient conditions and passed.The returned valve was videotaped as it cycled in the pulse duplicator to obtain footage showing valve leaflet motion.Video footage demonstrates that the valve opened and closed properly under the nominal stimulated patient test condition.Due to the nature of the complaint, no applicable dimensional testing is able to be performed.The complaint was confirmed by visual examination.The reported event was confirmed through returned product evaluation.A review of the dhr, lot history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.During the device evaluation, creases were observed on the leaflet, which could be attributed to workmanship issues during manufacturing.These creases could potentially lead to coaptation issues between the leaflets as reported.As such, available information suggests that manufacturing issue (workmanship) may have contributed to the complaint event.An investigation was initialed to further investigate.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506384
• MDR Report Key: 18618819
• MDR Text Key: 335086989
• Report Number: 2015691-2024-00686
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female